Setting exposure standards: a decision process

Abstract

Increased emphasis on routine screening of chemicals for potential neurotoxicity has resulted in the development of testing guidelines and standardized procedures. A multiphased, tiered-testing strategy has been proposed by numerous expert panels to evaluate large numbers of chemicals. In a regulatory context, however, a formal tiered-testing approach is not used, mostly because of the constraints of differing regulatory authorities and the potential cost of such a testing strategy. Instead, current regulatory decision making utilizes all available animal and human data to identify a critical adverse effect which is then used for setting standards. Although the current decision-making process does not use a formal tiered-testing approach, it appears to identify chemicals with neurotoxic effects. An analysis of U.S. Environmental Protection Agency integrated risk information system (IRIS) indicates that about 20% of the chemicals having standards or health advisories are based on neurotoxicity.